JPH0724687B2 - Percutaneous injection device and catheter introduction device thereof - Google Patents

Description

FIELD OF THE INVENTION The present invention relates generally to medical devices, and more particularly to devices for accessing a human or animal injection site. The device typically includes a catheter-enclosed solid introducer needle for accessing a surgically implanted port in communication with the blood vessel.

BACKGROUND OF THE INVENTION It is known to introduce fluids into a patient using catheters and insertion devices. The most common infusion device for intravenous infusion is a syringe with a hollow needle received in a catheter. After insertion, some blood is drawn into the syringe prior to removal of the syringe from the luer coupler and catheter provided at the free end of the catheter coupled to the fluid transfer system. These devices usually do not have a needle cover or protector before and after insertion.

Another known system for intravenous infusion is to have a flexible catheter placed in the hole of a hollow needle. After inserting the needle into the vein, the catheter is pushed through the hollow end of the needle with withdrawal of the needle. A significant drawback of this type of device is that the needle cannot be removed from the catheter once the insertion needle is withdrawn. Luer locks or other coupling mechanisms have diameters that are too large to pass through the mouth of the needle. Since the needle cannot be removed, it will continue to reside on the catheter outside the patient's body, causing continued problems.

A separable catheter insertion device is disclosed in US Pat.
No. 2,173. A longitudinal slot extends in the longitudinal direction of the needle and the hub attached to the needle. The slot facilitates removal of the catheter from the needle after inserting the catheter into the patient.

Filed October 31, 1986 and having application number 925313,
In the related application assigned to the assignee of the present application, a separable needle has the function of placing the catheter. Once the catheter is in place, the applicator acts to slit the needle, allowing it to be removed from the catheter and discarded.

The illustrated device with a hollow needle allows for blood extraction and reflux when inserted into a vein. In many cases, such features are important. However, there are other cases where it is not necessary. Reflux does not occur, especially if the catheter is inserted into a previously surgically implanted port. A port is a device that has a rubberized septum on the access side closest to the skin and a reservoir with a solid surface on the opposite side. The port also has a tube leading from the reservoir to an injection site such as a vein or other blood vessel. The device is placed under the skin to provide a bacterial coating and is conveniently located for the physician considering the intended use. Generally, ports are used to deliver chemotherapy
It may be used to advantage in areas where the patient's veins are destroyed or are easily destroyed, especially to avoid reflux and to provide a physician with safety when treating, for example, AIDS patients.

The above-mentioned syringes and other devices are known,
It is used to access veins, but is generally not suitable for accessing ports. Since the catheter does not have sufficient radial strength, fracture at the septum is unavoidable and the inner diameter of the catheter is small and limited by the size of the needle used.

A commonly known device for accessing a port is a hollow needle (without a catheter). A problem with hollow needles is the coring of the septum caused by the needle tip. Due to the corrosive nature of the drug introduced into the port and the venous system, it is important not to let the drug leak out of the port. The partitioning of the bulkhead inherently reduces the number of times the bulkhead can be passed without increasing the risk of leakage. Further, the fact of centering limits the size of the cross section of the needle that can be introduced into the port.

The infusion system disclosed in U.S. Pat. No. 4,569,675 briefly describes a needle device for introducing a catheter into a port, the needle being solid and fitted within the catheter. However, this device is very simple and does not show any radial stabilization before or after insertion or the needle container cover or any other feature or advantage of the present invention.

In summary, known catheter insertion devices include relatively flexible catheters, primarily intended for direct access to biological targets, usually veins. Generally, the port access device is a hollow needle and does not have a catheter. For insertion devices with a catheter, the catheter is necessarily small and lacks compressive strength. Coring is a problem for needles that access the port. The present invention uses a solid introducing member and a catheter covering it, and has a housing type holder having radial stability with respect to a needle and a catheter, and is particularly useful for accessing a port. Are suitable.

SUMMARY OF THE INVENTION The percutaneous infusion device includes a port, a solid introducer member, a semi-rigid catheter and a mechanism for retaining the introducer member and the catheter. The solid introduction member is a needle having a tip and a shaft, the shaft having a uniform cross-sectional shape along the distal end. The catheter is slidably fitted on the distal end of the introducer shaft. The retention mechanism retains both the introducer member and the catheter during insertion through the septum into the reservoir of the port and includes a pushing mechanism and a radial stabilizing structure for the needle introducer member and the catheter. Catheter
After insertion, it may be removed from the introducer member in the retention mechanism and the introducer member may be discarded away from the catheter that remains in communication with the reservoir.

The present invention is also directed to a method of using an access device, which inserts a solid introducer member surrounded by a catheter through human or animal skin and a septum of a port, and then withdraws the introducer member from the catheter. And removing it, and covering the introducing member so as to prevent accidental sticking.

In a particular embodiment of the method, the two fitted containers are locked together before the introducer member and the distal end of the catheter are exposed for insertion. In yet another specific embodiment, the introducer member is axially covered by the two containers when the introducer member is withdrawn and removed from the catheter, thereby mating when the introducer member is fully withdrawn. The two containers being locked are locked to each other and the introduction member remains covered.

The access device of the present invention is particularly advantageous in that the introduction member is rigid and the catheter surrounds it so that the septum does not core upon insertion. This allows a larger catheter to be inserted. Moreover, port life is essentially increased for a given size of introducer member. This is because the port is surgically implanted and the number of insertions or the life span for any deployed port is a critical functional parameter.

A further advantage of the device of the present invention is that it not only longitudinally coats the introducer member and the catheter before insertion, but also covers the introducer member when withdrawing the introducer member from the catheter after insertion, placing the covering mechanism in place. It is provided with a cover container mechanism that locks and prevents accidental sticking prior to disposal.

Yet another advantage of the present invention is that one of the specific embodiments of the catheter includes a first tube made of relatively hard Teflon,
A second tube of polyvinyl chloride (PVC) or other more flexible material with a connector therebetween. A luer lock or other suitable coupler is provided on the other end of the second tube. In either case, during insertion, the container mechanism pushes the needle and connector, and a force acts on the needle and the first tube of the catheter, which causes the septum to move to the needle rather than insert the catheter along the needle. Preventing sliding of the catheter along. A further advantage of the catheter is that the second tube is flexible and thus serves as a clamp. Furthermore, since the flexible second tube is on the side opposite to the connector, that is, the position where the force is applied, the flexible tube does not buckle during insertion.

While the present invention has been summarized above, the advantages described are best understood from the following brief description of the drawings and the accompanying drawings, which show preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded perspective view of an access device of the present invention, FIG. 2 is a perspective view showing a state in which a lock pin is removed from openings of aligned guard and handle members, and FIG. 3 is an introducing member and a catheter. FIG. 4 is a perspective view showing a state in which the distal end of the body is telescopically fitted into a guard member or a handle member, and FIG. FIG. 5 is a view showing a state in which the guard member is pulled out from the handle member in order to protect the introducing member when the introducing member is pulled out, and FIG. 6 is a state in which the covering container is removed from the catheter by the catheter clamp remaining on the catheter. FIG. 7 is a perspective view showing the catheter inserted into the implantation port, and FIG. 8 is a solid line showing a state immediately after removing the lock pin. In addition, the access device and the catheter after being inserted into the septum are shown by broken lines in a longitudinal sectional view of the access device. FIG. 9 is a longitudinal sectional view rotated 90 ° with respect to the device of FIG. FIG. 10 is a longitudinal sectional view showing a state after the introduction member is pulled out from the introduced catheter, FIG. 10 is an enlarged side view of the introduction member and the distal end portion of the catheter surrounding the introduction member, and FIG. 11 is the access device 11 of FIG. Fig. 11 is an end view seen from the line -11, Fig. 12 is an end view similar to Fig. 11 of a modified example of the catheter clamp, and Fig. 13 is a sectional view similar to Fig. 8 of a part of the access device showing the guide member, 14 is a cross-sectional view of another modification, FIG. 15 is a cross-sectional view of the catheter inserted into the guard and handle in the state after insertion, and FIG. 16 is seen from the line 16-16 in FIG. Fig. 17 is a sectional view taken along line 17-17 in Fig. 14, and Fig. 18 is an insert. FIG. 19 is a perspective view of another modification, and FIG. 20 is a perspective view of the needle and the stabilizing leg of the catheter in a solid line and a broken line in a withdrawal form.
19 is a sectional view of the end portion of the embodiment of FIG. 19, FIG. 21 is an enlarged side view of the end portion of the embodiment of FIG. 19, FIG. 22 is an explanatory view of the tip forming step in the needle forming method of the introducing member, 23 Figure is a side view of the needle and catheter, Figure 24 is a plan view of the needle and catheter of Figure 23, and Figure 25 is a force vs. insertion depth graph for two needle tips according to the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In the accompanying drawings, parts common to the drawings are denoted by the same reference numerals. More specifically, in FIG. 1, the access device of the present invention is indicated generally by the numeral 20. The device 20 includes an introduction member 22 with a hub 24. The introducer is slidably and snugly fitted within a semi-rigid catheter 26 having a coupler 28, typically a Luar lock, at one end. The hub 24 is fixed to the proximal end of the first container called the handle 30. A second container, called a guard 32, is telescopically fitted into the handle 30 so that it can be taken in and out. Lock pin 34 is a handle when pre-inserted
Hold 30 and guard 32 in fixed relation to each other. A clamp 36 for the catheter 26 is retained at the end of the guard 32 during pre-insertion.

In FIGS. 8 and 9, after surgically attaching a body 42 containing a cavity below skin 40, port 38 is shown enclosing reservoir 46 with the cavity covered by a littering septum 44. The body 42 is made of a biocompatible and drug compatible material such as titanium or a plastic material. Port 38 is located with septum 44 facing the access side closest to skin 40.
The main body 42 has a solid surface 47 on the side facing the partition wall 44. The body 42 has a flange 48 having a plurality of openings through which a suture 50 is passed to tie the port 38 to muscle or other tissue 52. The body 42 further includes a passage 46 from the reservoir 46 to the fitting 56, where the fitting 56 is a tube.
58 is stuck. The tube 58 is directed to the vein 60 or other injection site in a manner not shown.

The handle 30 is preferably cylindrical or hollow. A frustoconical hole 64 is formed in the proximal end 62. A plurality of ribs 66 extend inward from the inner wall 68 of the handle 30 at a position adjacent to the hole 64. The holes 64 and the tapered portions of the ribs 66 assist in fixing the hub 24 of the needle 22, which will be described in detail later. The remaining portion 70 of the handle 30 is a hollow cylinder. The distal end 72 has an inwardly tapered surface that assists in the mating of the guard 32 to the handle 30. The opening 74 is the handle 30
A side wall 68 near the distal end of the lock pin 34 is adapted to receive the lock pin 34.

The guard 32 preferably has a cylindrical sidewall 76. A flange 78 is formed at the distal end. A pair of cantilever arms 80 is formed at the base end of the side wall 76. Each arm 80 has a side wall 76
In contrast, it has a protrusion 82 extending outward. Preferably, the arm 80 does not extend completely to the proximal end 84. It should be noted that the protrusion 82 extends sufficiently outward through the opening 86 in the distal end of the handle 30. In addition, the guard 32 has an opening 88 in the side wall portion 76, and when the openings 74 and 88 of the cover 30 and the guard 32 are aligned in a row in this manner, the lock pin 34 is inserted, and the two containers are separated. It is adapted to be held in the first position and then fixed to the other members of the device 20.

As shown in FIG. 9, the handle 30 extends from the opening 86 to the rib portion 66.
Includes a pair of grooves 90 extending to. Each protrusion 82 is offset from opening 88 so that each groove 90 receives protrusion 82 when both containers are restrained in the first position. When the guard 32 is pushed into the handle 30 until the proximal end 84 contacts the rib 66 or the flange 78 contacts the distal end of the handle 30, each projection 82 follows the groove 90 and both. Guide the relative movement of the container. When both containers are in the second position, shown in phantom in FIG. 8, the guard 32 is fully telescopically inserted into the cover 32.

When the guard 32 is pulled out from the cover 30, each protrusion 80 is grooved.
Follow 90. In this case, the arm 80 causes the spring force to project.
There is no lock pin or other obstruction that stops the guard 32 until the container is pushed into the opening 86 to lock the containers in the third position relative to each other.

The introducer member 22 and catheter 26 have a distal end, a proximal end and a central portion therebetween. The hub 24 axially receives the introduction member 22 at the base end portion of the introduction member 22. The hub 24 and introducer member 22 are secured to each other with a medically recommended adhesive or other known method. The hub 24 has an outer frustoconical flange 92 that fits into the hole 64 and
It has a sufficient longitudinal dimension that extends approximately between each rib 66 and the proximal end of handle 30. The hub 24 also has a central boss 94 that receives the introduction member 22.

The introduction member 22 is a needle member having a solid shaft 96 having a tip 98. Shaft 96 is preferably a uniform cylinder. In particular, the portion of the shaft 96 that extends beyond the guard 32 when the device 20 is in the second position, i.e., the distal portion, has a uniform cross-sectional shape. The tip 98 preferably forms a polygonal facet. In this regard, FIGS. 23 and 24 show a preferred needle tip 198 for shaft 196 with catheter 200 received therein.
Tips 198 may be cast or pair of mating dies 2
It is formed by extruding metal when 02 and 204 approach each other as shown in FIG. Tip
198 is formed into a polyhedron from a conical shape or another shape as shown in FIG. Tip 198 has two knife-like edges 206 that extend in one direction and extend away from tip 208. Both edges 206 are formed at the ends of a somewhat flat burr portion 199 extending outwardly from the chip body. These flat burrs are sharper than the two flat facets that meet each other at the edges. Some material appears to build up in the transition region 210 between the tip and shaft. In addition, the transition region may be transversely extended or elliptical, as the tip preferably has one dimension longer than the other. Catheter 200
The ends of the must be shaped to closely match the transition region 210 to reduce any resistance that increases during insertion.

A force-insertion depth graph comparing the relative forces required to insert a conical tip and a polygon facet insert is shown in FIG. Curve 212 shows a force peak 214 when the conical tip penetrates the skin, and another force peak 216 is when the end of the catheter is inserted. Curve 218 shows a single peak at a much lower level than both peaks 214 and 216. The force curve due to the polygon facet tip is much lower because the knife-like edge cuts open rather than tears the skin.

The catheter 26 is made of a material having a radial and longitudinal compressive strength such that the septum can be bent without damage during and after insertion of the catheter, and without tangling with the skin after insertion, such as Teflon. Made of material. Advantageously, the catheter 26 has a relatively large inner diameter to closely receive the introducer member 22. The distal end 106 of the catheter 26 has a tapered surface that matches the geometry of the tip 98 of the introducer member 22.

The most convenient coupler fixed to the proximal end of catheter 26 is the known luer lock 28. In any case,
The coupler shown in FIGS. 8 and 9 has a central cavity 100 that receives a boss 94. Flange 102 is a coupler
Extending outwardly from the wall of cavity 100 at the proximal end of 28. Catheter 26 is secured to body 104 of coupler 28 by a medically acceptable adhesive or otherwise.
The catheter 26 opens into the cavity 100.

Introducing member 22 and catheter 26 have a substantial length relative to each other such that flange 102 receives boss 94 within cavity 100.
When fitted to the hub 24 with a tip 98, the tip 98 and the end 106 of the catheter 26 are adapted to fit as closely as possible, such as the conical shape shown. Once the hub 24 is received and secured in the hole 64 of the handle 30, the introducer member 22 and catheter 26 pass over the handle 30 and guard as the handle 30 and guard 32 are restrained in the first position.
It extends up to half the length of 32 strokes. In this way, when the handle 30 and guard 32 are moved to the second position, the introducer member 22 and catheter 26 extend far enough beyond the flange 78 of the guard 32 to ensure sufficient insertion into the port 38. It has become.

The lock pin 34 includes a pin 108 fixed to the plate-shaped handle 110. The pin 108 fits into the openings 74 and 88 and extends through the catheter 30 and introducer member 22 proximately along the axis of the handle 30 and guard 32 without obstructing them. It has a geometric dimension.

The clamp 36 at least partially protects the tip of the introduction member 22 arranged in the guard 32 before insertion, and
It guides and supports the introduction member 22 and the catheter 26 during insertion, and further has a function of remaining on the catheter 26 after insertion and imparting a function of restraining the catheter 26.
Thus, the clamp 36 has a flat member 112 and a hub 118. The flat member 112 has a semicircular end 114 (see FIG. 1) that has a diameter smaller than that of the flange 78 and is arranged concentrically at one end, and extends outwardly beyond the flange 78 at the other end 116. It has a handle part. A hub 118 is formed in the flat member 112, and the hub 118 is slidably fitted on the hollow end of the guard 32. The hub 118 has one or more ribs 120 (see FIG. 9) along the side surface. At the end of the guard 32, a plurality of grooves 1 for receiving each rib 120 with friction resistance
22 are formed which hold a clamp 36 at the end of the guard 32 until the guard is moved therefrom. Along the axis of the hub 118, an opening 124 is formed that widens towards the guard 32. The opening 124 has a circular shape slightly larger than the circular dimension of the catheter 26. The slot 126 (see FIG. 1) extends toward the end 116 and has a width that tapers away from the opening 124. Catheter 26
When is pushed into the slot 126, the slot 126 acts to compress and eventually close the wall of the catheter 26. As shown in FIG. 11, aperture 130 separates opening 124 from slot 126. In this way
On the wall of the opening 124, the introduction member 22 and the catheter 26 are separated by the partition wall 4.
As it is pushed into 4 and inserted, it acts to hold both of them. The iris 130 prevents the introducer member 22 and the catheter 26 from getting stuck in the slot 126.

As shown in FIG. 12, in another embodiment, the same constituent parts are indicated by adding a dash sign to the corresponding numeral sign. The clamp 36 'includes a slot 132 that ramps up from the slot 126 to the opposite side, and the slot 132 and the opening 124.
Clamp 36 except that it has a second aperture 134 between
Is similar to. Slot 132 is for Catheter 2
If it is not desired to have the clamp 36 'contact the 6 at all times, the clamp 36' can be removed from the catheter 26. The diaphragm 134 has the same size and function as the diaphragm 130. Further, according to this embodiment, it is preferable to include a key (not shown) in the guard 32 that fits into the slot 132 to ensure proper support of the introducer member 22 and catheter 26.

Stabilizing member 136 is another mechanism for supporting catheter 26 and introducer member 22 near the distal end of guard 32 as shown in FIG. The stabilizing member 136 has a frustoconical end 138 that matches the enlarged portion of the opening 124. The proximal end 140 of the stabilizing member 136 extends to the side wall 76, which provides stabilization and fixed support. The stabilizing member 136 has a central opening 142 that is slightly larger than the catheter 26 to provide the desired support of the central portion of the introducer member 22 and catheter 26. A large cavity 144 is formed in the proximal end of the stabilizing member 136, and after insertion and then withdrawal of the introducing member 22, the stabilizing member 136 is movable towards the coupler 28 and the wall of the cavity and the coupler. A friction fit is made between the 28 main bodies 104. Preferably, the opening 142 is sized to be several times larger than the opening 124 of the clamp 36, and if desired, the stabilizing member 136 may include
The shaft 22 and the catheter 22 are supported more firmly than the above.

A method of using the device 20 will be described with reference to FIGS.
In general, the concept of device 20 is to insert a solid introducer, which is axially surrounded by a catheter, through the skin of a human or animal and the septum of the port. Thereafter, the introducer member is withdrawn and removed from the catheter, leaving the catheter installed through the skin and septum. A fluid mechanism is additionally connected to the coupler 28, and a port 38 is provided through the coupler 28 and the catheter 26.
The flow rate of the liquid to the storage unit 46 can be measured.

More specifically, as shown in FIG. 2, the handle 32 and the guard 32 are released by removing the lock pin 34 from the openings 74 and 88. The lock pin 34 has no other function and may be discarded. As shown in FIG.
Grasp handle 30 with one hand and clamp with the other 36
Alternatively, by gripping the flange 78, the guard 32 is telescopically inserted into the handle 30, and the guard 32 is inserted into the handle 30.
Is pushed. This operation is performed by the introduction member 22 and the catheter.
Expose both ends of 26. Prior to inserting the catheter and introducer, the perimeter of port 38 should be palpated and
38 edges are found. Thereafter, the catheter and introducer are held at an angle of about 90 ° to the skin and inserted into the skin and septum. The device 20 is pushed towards the body until the tip 98 reaches the bottom of the reservoir 46. As shown in FIG. 5, the withdrawal of the introducer member 22 to the condition that it is covered by the handle 30 and the guard 32 holds the guard 32 in a fixed relationship relative to the skin and with an empty hand. This is accomplished by pulling back on the handle. The catheter 26 will be held by the strong frictional force acting between the catheter and the septum. It is sufficient that the force overcomes all the smaller frictional forces that occur between the introducer member 22 and the catheter 26 and between the coupler 28 and the boss 94 in the cavity 100. In this way, the catheter 26 and coupler 28 remain relatively stationary while the handle 30
Introducing member 22 will be withdrawn from catheter 26 as is removed from the patient. As shown in FIG. 6, when the handle 30 is sufficiently pulled apart, the arm 80 pushes the protrusion 82 into the opening 86 to constrain the handle 30 and the guard 32 in the third position relative to each other, so that the introducing member 22 is lengthened. Directionally surrounded by the container. The clamp 36 is withdrawn from the distal end of the guard 32 and the introducer 22, handle 30 and guard 32 are separated from the catheter 26 and coupler 28.
The clamp 36 remains on the catheter 26 between the coupler 28 and the patient's skin, as shown in FIG. catheter
A dressing 128 may be used to hold 26 to the patient's skin, thereby relieving catheter 26 pressure on port 38.

Another embodiment of the access device of the present invention is shown in FIGS.
It is designated generally by 20 "in FIG. 18. This device 20"
Includes an introduction member 22 "having a hub 24". This introducer fits into the catheter 26 ". The hub 24" holding the introducer 22 "is rigidly fixed to the proximal end of the handle 30". The guard 32 "can be telescopically inserted into and removed from the handle 30". At the time of preliminary insertion, a lock pin (not shown) similar to the lock pin 34 fixes the handle 30 ″ and the guard 32 ″ in a predetermined relationship.

Catheter 26 "includes first and second tubes 150 and 152 with a connector 154 therebetween.
150 is less flexible than the second tube 152. First tube
150 is preferably made of a material such as Teflon to provide radial and longitudinal compressive strength to the extent necessary to insert and retain the introducer member and the tube in the septum. The second tube 152 is preferably made of an elastic material, such as polyvinyl chloride (PVC), that is crushed under restraint and capable of returning to its original form when released. A catheter having a semi-rigid tube and a flexible tube serves both the purpose of inserting under the desired and possible environment and the purpose of constraining the catheter so that it does not need to be constantly open. For example, when removing the first liquid and injecting the second liquid, it is preferable to restrain the catheter. Also, the catheter is made short and can draw blood if desired when other fluid systems are removed.

Connector 154 provides a connection between low flexibility tube 150 and high flexibility tube 152. Each tube has a different inner and outer diameter and the connector 154 has a suitable boss and passage for receiving each tube. In particular, the first tube 150
Is an axial passage 156 extending longitudinally of the connector 154.
It is inserted and fixed inside. The flexible tube 152 covers the boss 158 provided at the base end of the connector 154 and is fitted therein. The connector 154 is formed with a wing member 160 extending transversely to the handle 30 ".
The wing member 160 has sufficient thickness and length, and the handle 30 ″
The first tube when receiving and properly supporting the force of
It is structured to transmit sufficient force to 150.

Catheter 26 "includes a luer lock or other suitable coupler 28" at the proximal end of flexible tube 152. Coupler 28 ″ and connector with medically acceptable adhesive
154 is fixed to the first and second tubes 105 and 152.

The handle 30 "is a hollow cylindrical body. The proximal end 62" is formed with a frustoconical hole 64 "for receiving the hub 24". The hole 6
A plurality of ribs 162 are provided from 4 "to the distal end of the handle 30, the coupler 28" being a boss 94 "of the hub 24" of the coupler 28 ".
The distal end 164 extends to a position where it contacts the proximal end of the wing member 160 when received by the. Each rib 162 extends sufficiently inward in the transverse direction and is in contact with a wing member 160 that extends outward in the transverse direction from the axis of the handle 30 ″. A coupler 28 ″ is allowed to pass between them.

The guard 32 ″ is cylindrical and has a stabilizing member 13 at its distal end.
6 ". The stabilizing member 136" is removable from the guard 32 "and separates from the catheter 26" when the stabilizing member is removed from the guard 32 ". The handle 30 "and guard 32" include an opening that cooperates with a locking pin that holds both containers in the pre-inserted position.

With respect to the locking mechanism after insertion, the guard 32 ″ includes a relatively short perimeter flange 168 (see FIG. 18) at each end. The handles 30 ″ are formed along opposite side walls to at least the distal end of the wing member 160. Section with a U-shaped channel extending from the base to the proximal end of the handle 30 ″. Each short flange 168
Are guided along channel 170 in a similar manner as projection 82 follows groove 90 in device 20 described above. The handle 30 ″ has an arm 80 ″ cut into the outer wall of each channel 170. Each arm 80 ″ is cantilevered from its proximal end. Near the distal end, each arm has a ramp 172 that extends inwardly toward the distal end. A groove 174 defines the ramp.
It is formed following 172. The wall 17 is provided at the end of the groove 174.
6 is formed. As the guard 32 ″ slides from the second position toward the third position as described above with respect to the device 20, each flange 168 pushes the arm 80 ″ outward as the flange 168 moves along the ramp 172. . Each flange 16
When 8 is received in groove 174, guard 32 ″ and handle 30 ″
Are constrained to each other in the third position.

Preferably, each channel 170 is arranged at 90 ° to wing member 160. Such an arrangement can be achieved by providing a suitable pair of notches in the coupler 28 "that receives the protrusion 178 (see FIG. 7) extending from the hub 24".

The usage of the access device 20 ″ is similar to the device 20 described above and will not be described further.

Another modification of the access device of the present invention is shown in FIGS.
It is shown in FIG. 21 and is designated by the numeral 20. As shown in FIG. 19, the device 20 has a handle container 30 and a guard container 32. Both containers have a slightly different shape from the above-mentioned embodiment, but all the features of the above-mentioned embodiment are included in the device 20 except for the pre-insertion locking mechanism. The mechanism 220 for stabilizing the needle introduction member and the catheter at the distal end of the device is different from the mechanism described above and will be described in detail below. Another noteworthy difference is the handle container 30
Includes a radially extending wall 222 which contacts the wing member of the catheter connector to provide a pushing force on the catheter during insertion.

The stabilization mechanism 220 includes a pair of identical arms 224. Each arm 224 has a mating groove 226 in which the catheter 150 and the needle contained therein are received. Each groove 226 is of sufficient length to provide radial support at the end of the device 20 to prevent bending or entanglement during insertion. Each arm 224 cooperates with the containers 30 and 32 to form a first and second locking mechanism 228 and 230 which holds each arm 224 together in the pre-insertion and insertion positions of the device 20. . Locking mechanism 228 includes a notch 232 outside the distal end of each arm. When the arms 224 are pressed against the flange 234 of the guard container 32, the notches 232 disengage each arm.
The extension part of 224 is projected into the opening 238 of the flange 234, while the recessed part of the end part of each arm 224 is fitted to the rear side or the base end side of the flange 234. Lock mechanism 230
Holds the arm 224 against inadvertent slippage from the flange 234. As shown in FIG. 21, as shown in FIG.
Has slots 242 on opposite sides extending from flange 234 to recessed ledge 244. The guard 32 has cantilever lever members 246 on both sides of the slot 242. These cantilever lever members extend toward the flange 234. Each cantilever member 246 includes a small protrusion 248 that extends into the slot 242, which protrusion mates with a notch 250 in the arm 224.

The handle container 30 has a ridge 25 at its distal end on opposite sides thereof.
Having 2. Each arm 224 has an outwardly facing slot 254 into which the protrusion 252 fits. slot
254 terminates at bridge 256. When the needle is pulled out from the catheter after inserting the catheter, the handle container 30 is pulled away from the guard container 32, and the protrusion 252
Slides into the slot 254 and immediately contacts the bridge 256 as the arm 242 is withdrawn, causing the cantilevered lever member 246 to flex and cause the protrusion 248 to exit the notch 250. When the arm 224 is pulled away from the flange 234, the connector 154 contacts the wedge-shaped proximal end of the arm 224 and rotates them about the bridge 256, which bridges the recess 244 and wall of the guard container 32. It is captured between the protrusions 252 of the handle container 30. The guard container 32 has an elongated hollow interior 258 that receives the connector 154 as it moves relative to the arm 224 and maintains a particular orientation. The arm 224 pivots sufficiently outwardly through the slot 242 to pass the connector 154 as well as the coupler 28 between them, thus completely isolating the catheter from the rest of the device 20.

The device 20 is used in the same manner as the devices described above, and the operation of the stabilizing mechanism is as described above. It should be noted that the method of manufacturing the device of the present invention may include a new step of forming a knife-like edge extending from the tip of the solid rod, as shown in FIG. 22, before attaching the rod to the handle container. There must be. The catheter is then slid over the rod. As the guard container slides into the handle container, a stabilizing mechanism engages the circumference of the catheter and rod combination. In one embodiment, a locking mechanism is used to hold the guard and handle container in the pre-insertion position. Such a locking mechanism is not used with the device 30 as it will hold the packaging member in place and will not be removed until the packaging member is in use with the device 30. As described above, the method of use is as described above.

Above, the preferred embodiments and modified examples of the device of the present invention, the manufacturing method and the using method thereof have been described in detail, and the advantages and effects of the configuration have been clarified. However, it should be understood that equivalents are possible. Therefore, changes in the disclosed structure and the method of using the present invention, particularly in terms of shape and size and arrangement, should be made to the maximum extent possible within the general concept of the technical matters expressed in the following claims. It should be understood that additions are within the principles of the invention.

Claims (14)

[Claims] 1. A human or animal body including a housing that forms a reservoir with a self-sealing partition wall provided on the access side and a solid surface provided on the side facing the access side, and having an outlet tube. An implantable injection port member adapted to place the septum under the skin and connect the outlet tube to an injection site of the living body, a needle member, and a portion that fits with a part of the needle member. Catheter means for accessing the reservoir of the injection port member, and holding means for holding the needle member and the catheter means for inserting the needle member and the catheter means into the septum. Including the pressing means for pressing the member and the catheter means, and at the end closest to the insertion site during insertion. Serial includes a needle member and a stabilizing means which enables separate from the holding means said catheter means after stabilize and catheterized means in the radial direction, and characterized by being configured from the holding means,
Transdermal injection device. 2. A device according to claim 1, wherein the catheter means comprises contact means for contacting the pushing means of the holding means, connecting means for connecting with an attachment member, and elastic crushing means for elastically crushing between the two means. 3. The catheter means further comprises a first tube of a low flexibility material forming the distal end, the elastic crushing means comprises a second tube of a highly flexible material, and the contacting means comprises the first tube. The apparatus of claim 2 including a connector connecting the first and second tubes. 4. The contact means includes a wing member in the connector, and the wing member is pressed by the pressing means.
The apparatus according to item 3. 5. A solid needle member having a proximal end portion and a distal end portion, a catheter means having a proximal end portion and a distal tip and slidably received over the needle member, a proximal end of the needle member. First part is accommodated and fixed
A housing member and a second housing member receivable over the needle member and the distal tip of the catheter means, wherein the first and second housing members are telescopically fitted to provide the needle member and catheter means. Is slidable between a stretched first position in which the distal tip is received in the second housing member and a compressed second position in which the distal tip of the needle member and catheter means is exposed. The catheter introducing device, wherein the first and second housing members have a combined length that is longer in the first position than in the second position. 6. A rigid means fixed to said catheter means for receiving a pressing force, said first housing means said catheter means when the housing member is contracted from a first position to a second position. The catheter introducing device according to claim 5, further comprising a pressing means for applying a pressing force to the rigid means of the inside. 7. The catheter introducer set forth in claim 6 wherein the rigid means of the catheter means includes a wing member extending transversely to the catheter means. 8. The catheter means includes a connector at its proximal end, the device further comprising a second housing member from the first position to the second position.
The catheter introducer set forth in claim 5 including a guide member separably attached to the second housing member for guiding the needle member and the catheter means outboard of the second housing member when compressed into position. 9. A fifth member, wherein the guide member has an opening smaller than the connector, and the assembly further includes means for enlarging the opening so that the connector extends through the enlarged portion.
The catheter introducing device according to the paragraph. 10. A solid needle member having a proximal portion and a distal portion, a catheter means having a proximal portion and a distal tip, slidably received over the needle member, and a first portion having a distal portion. A sleeve member and a second sleeve member having a distal end and a proximal end, the proximal end telescopically matingly slidably adapted to the distal end of the first sleeve member. The sleeve members are extended to each other to enclose the needle member and the catheter means in a first extended position and the sleeve members are compressed to each other so that the needle member and the catheter means are in the second position.
A shortened position extending outwardly from the distal end of the sleeve member and a second extended position in which both sleeve members surround the needle member after inserting the needle member and catheter means and withdrawing the needle member from the catheter means, A catheter introducer having a combined length that is longer in the extended position than in the shortened position. 11. The catheter introducer set forth in claim 10 further including locking means for locking both sleeve members in the second extended position. 12. The catheter introducer set forth in claim 5 wherein the second housing member includes a stabilizing member for stabilizing the catheter and needle prior to and after insertion into the patient. 13. A first orientation wherein the stabilizing member is separable from the housing member and defines a smaller opening than the connector member to retain the catheter at least partially within the first and second housing members. A second orientation that defines a sufficiently large opening to permit withdrawal of the catheter from the first and second housing members.
Item 12. The catheter introducing device according to Item 12. 14. The stabilizing member includes at least one arm having a groove for receiving a catheter and a needle, the groove being relative to the catheter and the needle to prevent bending or entanglement during insertion into a patient. 14. The catheter of claim 13 having a length sufficient to provide radial support and the at least one arm is pivotally received in a longitudinal slot in the second housing member. Introduction device.